Evaluation of a Self-compassion App in People With Cancer: Feasibility, Acceptability and Changes in Well-being

NCT07415629 | Completed

• 1 other identifier: 17009
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

To support patients with cancer with managing psychological distress due to their illness and treatment, a self-help digital Compassionate Mind Training (i.e., Compas-Y App) was developed in co-creation with people with cancer and nurses in oncology. This study will examine : What is the feasibility, acceptability, and effectiveness of Compas-Y app in distressed cancer patients? The reseachers use a multiple baseline design, with a 2-3 week baseline phase and a 6-week intervention phase. Adult patients (\>= 18 years) will be approached for the study, who finished their medical treatment and who experience a reduced well-being. To examine the effects of Compas-Y, the researchers will examine changes in self-compassion and self-criticism (primary outcomes) and mindfulness, emotion regulation strategies, and positive and negative affect (secondary outcomes). We will use EMA items to assess momentary levels of these primary and secondary outcomes. These assessments will be 3 times per week at 7:00 PM, both during the 2-3 week baseline phase ( 6-9 assessments in total) and the 6-week intervention phase (18 times assessments in total). The expectation is increases in self-compassion, reductions in self-criticism, and improved affect as well as improved mindfulness and emotion regulation. In addition, the expectation is more improvement in outcomes in those patients with greater usage of the app.

Conditions

Cancer

Keywords

Compassion; Self-criticism; App; Emotion Regulation; Intervention; EMA assessment; Self-compassion; Self-help

Outcome Measures

Primary Outcomes (2)

• Self-compassion

  Momentary self-compassion is assessed using ecological momentary assessment (EMA) items. We use five items based on the Sussex-Oxford Compassion for the Self Scale (SOCS-S), with each of the five facets of self-compassion covered by one EMA item: (1) "I'm quick to notice early signs of distress in myself.", (2) "I understand that feeling upset at times is part of human nature.", (3) "I feel kindly towards myself.", (4) "I connect with my own suffering without judging myself.", (5) "I try to look after myself." Items are rated on a 0-100 visual analogue scale with verbal anchors (0 = "Not at all," 25 = "A little," 50 = "Moderately," 75 = "Quite a bit," 100 = "Very much").

  During baseline period, participants fill out 3 assessments each week on Tuesday, Thursday and Saturday at 7.00 PM for 2 to 3 weeks (depending on randomisation). During the 6-week intervention, they will fill out 3 assessments each week.

• Self-criticims

  Momentary self-criticism is assessed with a single item derived from the Self-Compassion Scale: "I am a bit cold-hearted towards myself when I'm experiencing suffering", rated on a 0-100 visual analogue scale with verbal anchors (0 = "Not at all," 25 = "A little," 50 = "Moderately," 75 = "Quite a bit," 100 = "Very much").

  During baseline period, participants fill out 3 assessments each week on Tuesday, Thursday and Saturday at 7.00 PM for 2 to 3 weeks (depending on randomisation). During the 6-week intervention, they will fill out 3 assessments each week.

Secondary Outcomes (3)

• Mindfulness

  During baseline period, participants fill out 3 assessments each week on Tuesday, Thursday and Saturday at 7.00 PM for 2 to 3 weeks (depending on randomisation). During the 6-week intervention, they will fill out 3 assessments each week.

• Affect

  During baseline period, participants fill out 3 assessments each week on Tuesday, Thursday and Saturday at 7.00 PM for 2 to 3 weeks (depending on randomisation). During the 6-week intervention, they will fill out 3 assessments each week.

• Emotion regulation

  During baseline period, participants fill out 3 assessments each week on Tuesday, Thursday and Saturday at 7.00 PM for 2 to 3 weeks (depending on randomisation). During the 6-week intervention, they will fill out 3 assessments each week.

Study Arms (1)

Digital self-help self-compassion app (Compas-Y)

EXPERIMENTAL

6-week self-help app intervention

Other: A digital self-help self-compassion app intervention

Interventions

A digital self-help self-compassion app intervention OTHER

A 6 week self-help self-compassion app intervention providing psychoeducation and brief exercises via the app

Digital self-help self-compassion app (Compas-Y)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged 18 and older;
• Diagnosed with cancer (stage I-III);
• Completed medical treatment in the past 2 years;
• Reporting a reduced well-being (Mental Health Inventory (MHI-5) = \<76 score (Kelly et al., 2008) \[lower scores indicate worse well-being\]);
• Proficient in Dutch;
• willing to try out the app for about 2 hours per week during 6 weeks and fill in the questionnaires for 8-10 weeks;
• Participants should have a smartphone, computer or tablet with internet access for digital intervention and data-collection.

You may not qualify if:

• \. Participants have a current psychological or psychiatric treatment outside this study. 2. Insufficient Dutch language skills to follow the group sessions or complete homework exercises

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

Department of Health Sciences, Health Psychology Section, University Medical Center Groningen

Groningen, 9713 AV, Netherlands

Location

Related Publications (3)

• Austin J, Drossaert CHC, Schroevers MJ, Sanderman R, Kirby JN, Bohlmeijer ET. Compassion-based interventions for people with long-term physical conditions: a mixed methods systematic review. Psychol Health. 2021;36(1):16-42. doi:10.1080/08870446.2019.1699090

  BACKGROUND

• Austin J, Drossaert CHC, van Dijk J, et al. Integrating Top-down and Bottom-up Requirements in eHealth Development: The Case of a Mobile Self-compassion Intervention for People With Newly Diagnosed Cancer. JMIR Cancer. 2022;8(3):e37502. Published 2022 Aug 1. doi:10.2196/37502

  BACKGROUND

• Austin J, Schroevers MJ, Van Dijk J, et al. Compas-Y: A mixed methods pilot evaluation of a mobile self-compassion training for people with newly diagnosed cancer. Digit Health. 2023;9:20552076231205272. Published 2023 Oct 19. doi:10.1177/20552076231205272

  BACKGROUND

MeSH Terms

Conditions

Neoplasms; Alzheimer Disease; Emotional Regulation

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Self-Control; Social Behavior; Behavior

Study Officials

• Ernst Bohlmeijer, Prof. dr.

  Twente University Department of Psychology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2025
• First Posted: February 17, 2026
• Study Start: April 27, 2024
• Primary Completion: September 1, 2024
• Study Completion: May 1, 2025
• Last Updated: February 17, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Access Criteria: Meta data accessible via the University Research Portal

Locations

NL (1)